Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Do not use this medication if you:

• are allergic to estradiol or any ingredients of this medication
• are breast-feeding
• are or may be pregnant
• have, have had, or may have breast cancer
• have a blood clotting disorder
• have a history of known or suspected estrogen-dependent tumours (e.g., endometrial cancer)
• have active phlebitis (inflamed varicose veins)
• have classical migraines (migraines with aura)
• have endometrial hyperplasia (thickening of the inner lining of the uterus)
• have liver dysfunction or disease
• have or have had a stroke, heart attack, or coronary heart disease
• have or have had blood clots in the legs or lungs, or coronary thrombosis
• have partial or complete loss of vision from eye disease related to circulation problems
• have porphyria
• have unusual vaginal bleeding that has not been checked by a doctor

Note the following important information about estrogen replacement therapy:

The Women's Health Initiative (WHI) study results indicated an increased risk of heart attack, stroke, breast cancer, blood clots in the lungs, and blood clots in the leg veins in postmenopausal women during 5 years of treatment with 0.625 mg conjugated equine estrogens and 2.5 mg medroxyprogesterone compared to women receiving sugar tablets. Other combinations of estrogen and progestins were not studied. However, until additional data are available, the risks should be assumed to be similar for other hormone replacement products. Therefore,

• estrogens with or without progestins should be used at the lowest dose that relieves your menopausal symptoms for the shortest time period possible, as directed by your doctor.
• estrogens with or without progestins should not be used to prevent heart disease, heart attacks, or strokes

Allergy: Contact allergy, such as itching and redness, is known to occur with the application of estrogen to the skin. Although this allergy is extremely rare, people who develop skin reactions or contact sensitization to any component of the medication are at risk of developing a severe allergic reaction with continued use. If you have a skin reaction to the patch, contact your doctor for advice.

Blood clotting disorders: Estrogens with or without progestins are associated with an increased risk of blood clots in the lungs (pulmonary embolism) and legs (deep vein thrombosis). If you have or have had a heart attack, a stroke, heart disease, a blood clot in your leg, or have medical conditions that increase your risk of blood clots, you should not use this medication.

The risk of developing blood clots also increases with age, a personal or family history of blood clots, smoking, and obesity. It is also increased if you are immobilized for prolonged periods and with major surgery. If possible, this medication should be stopped 4 weeks before major surgery. Talk about the risk of blood clots with your doctor.

Blood pressure: Women may experience increased blood pressure when using estrogen replacement therapy. Talk to your doctor about how often you should have your blood pressure checked.

Bone disease: If you have bone disease due to cancer or a metabolic condition causing too much calcium in your body, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Breast and ovarian cancer: Studies indicate an increased risk of breast and ovarian cancer with long-term use of estrogen replacement therapy. Women with a history of breast cancer should not use estrogens. Women who have breast nodules, fibrocystic disease, abnormal mammograms, or a strong family history of breast cancer should be closely monitored by their doctor.

Women taking estrogens should have regular breast examinations and should be instructed in breast self-examination. The estradiol patch must not be applied to the breasts, as it may have harmful effects on the breast tissue.

Dementia: Women over the age of 65 receiving combined hormone replacement therapy (estrogen and progestin) may be at increased risk of developing dementia (loss of memory and intellectual function). If you are over 65, talk to your doctor about whether you should be tested for dementia.

Diabetes: Estrogens may affect blood sugar control. If you have diabetes or are at risk of developing diabetes (e.g., have a family history of diabetes, have high blood pressure or high cholesterol, or are obese), carefully monitor your blood glucose levels while using this medication.

Endometrial cancer: There is evidence from several studies that estrogen replacement therapy can increase the risk of cancer of the endometrium (lining of the uterus). Taking a progestin at the right time along with the estrogen reduces this risk of endometrial cancer to the same level as that of a woman who does not take estrogen. For this reason, all women who have not had their uterus removed should also take a progestin if they are using estrogens.

If you develop any abnormal vaginal bleeding while using this medication, contact your doctor. If you have or have had endometrial cancer, you should not use this medication.

Endometriosis: Estrogen replacement therapy can cause endometriosis to reappear or get worse. If you have or have had endometriosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Fibroids: This medication may worsen fibroids by causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.

Fluid retention: Estrogen may cause fluid retention, and worsen heart disease, kidney disease, or asthma. Talk to your doctor if you have any concerns. If you experience worsening of these conditions while using this medication, contact your doctor.

Follow-up examinations: It is important to have a follow-up examination 3 to 6 months after starting this medication to assess your response to treatment. Examinations should be done at least once a year after the first one.

Gallbladder disease: This medication can aggravate gallbladder disease or increase the risk of developing it. If you have gallbladder disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease and stroke: Studies indicate an increased risk of heart disease and stroke with estrogen (with or without progestin) for postmenopausal women. If you experience symptoms of a heart attack (chest pain, tightness or pressure, sweating, nausea, feeling of impending doom) or stroke (sudden dizziness, headache, loss of speech, changes in vision, weakness or numbness in the arms and legs) while taking this medication, get immediate medical attention.

High cholesterol or triglycerides: Estrogen may increase triglyceride levels in those who already have high levels. This has been observed particularly when estrogen is taken orally – the risk is reduced with use of the patch. Your doctor will monitor your cholesterol and triglyceride levels while you are taking this medication.

Kidney function: Estrogen can affect how calcium and phosphorus are used by your body. If you have kidney disease, this may be a concern and you should discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have reduced liver function, you may require special monitoring by your doctor while you use this medication. Make sure to tell your doctor if you have ever had liver problems. People with active liver disease or liver tumours should not use the estradiol patch.

If you experience symptoms of liver problems (e.g., yellowing of the skin or eyes, abdominal pain, loss of appetite, dark urine, pale stools, nausea, or vomiting), contact your doctor immediately.

Migraine headaches: If you have migraines with aura (headache is associated with symptoms such as flashes of light, tingling sensations, blind spots, muscle weakness, difficulty speaking either before or during the headache), you should not use this medication.

For some people who experience migraine headaches, estrogen can aggravate the condition. Talk to your doctor if you notice any change in your migraine pattern while using estrogen.

Seizures: Estrogens may increase your risk of having a seizure. If you have a seizure disorder or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Thyroid disease: Estrogen may affect how thyroid hormone is used by the body. If you are taking thyroid medication to supplement an underactive thyroid gland, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: Estrogen should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking estrogen, it may affect your baby. This medication is not recommended for breast-feeding women.

Children: The safety and effectiveness of using this medication have not been established for children.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• bloating
• breast tenderness
• change in sex drive
• contact lens discomfort
• darkening of the skin around areas where the patch is applied
• dry eyes
• excessive hair growth
• hair loss
• headache
• increased vaginal secretions
• memory problems
• nausea
• nervousness
• redness or irritation underneath or around the area of the skin on which the patch is applied
• trouble sleeping
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• breast lumps
• discharge from nipple
• easy bruising
• frequent or prolonged, exceptionally heavy periods
• flu-like symptoms
• fluid retention (swelling of the lower legs, ankles, feet, or fingers)
• high blood pressure
• lower abdominal pain or swelling, painful or heavy periods
• migraine headache
• symptoms of an infection (e.g., fever)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of  liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of gallstones (e.g., pain in the upper right abdomen, pain between the shoulder blades or in the right shoulder)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• coughing blood
• headache (sudden or severe)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• sudden shortness of breath, coughing up blood, or sharp pain in chest
• sudden vision changes (such as partial or complete loss of vision, double vision)
• symptoms of a severe allergic reaction (e.g., hives; difficult breathing; swelling of the face, mouth, throat, or tongue)
• symptoms of a stroke (e.g., sudden and severe headache, sudden vision changes, sudden difficulty speaking, sudden weakness or numbness in arms or legs, sudden dizziness, fainting, or vomiting)
• tender or painful inflammation of the veins (e.g., pain in groin, calf)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

There may be an interaction between the CLIMARA patch and any of the following medications:

• abiraterone
• alcohol
• amiodarone
• anastrozole
• antidiabetes medication (e.g., insulin, metformin, glyburide)
• apixaban
• aripiprazole
• argatroban
• ascorbic acid (Vitamin C)
• atorvastatin
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• barbiturates (e.g. pentobarbital, phenobarbital)
• bosentan
• carbamazepine
• carvedilol
• celecoxib
• oral corticosteroids (e.g., dexamethasone, prednisolone, prednisone)
• cyclosporine
• cyproterone
• dabigatran
• deferasirox
• dehydroepiandrosterone
• dipyridamole
• dronedarone
• doxorubicin
• efavirenz
• etravirine
• grapefruit juice
• heparin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hyaluronidase
• hydrocodone
• levothyroxine
• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• medications used to treat high blood pressure (e.g., atenolol, rampiril, enalapril, lisinopril, amlodipine)
• mefloquine
• nefazodone
• nevirapine
• oxcarbazepine
• phenytoin
• prazosin
• primidone
• progesterone
• propranolol
• quinidine
• quinine
• rifabutin
• rifampin
• rivaroxaban
• ropinirole
• St. John's wort
• saw palmetto
• simeprevir
• somatropin
• soybean
• tacrolimus
• tamoxifen
• telaprevir
• thalidomide
• theophylline
• thyroid replacements (e.g., dessicated thyroid, levothyroxine)
• trazodone
• tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)
• ursodiol
• verapamil
• vinblastine
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

A new patch should be applied to your skin on the same day once a week (i.e., the patch should be changed once every 7 days). Women who have not had a hysterectomy (removal of their uterus) must also take a progestin while they are taking this medication to prevent certain side effects associated with the use of estrogen.

The patch is often applied to the buttocks, lower abdomen, or hip. Many women have found that less skin irritation occurs when the patch is applied to the buttocks. Talk to your doctor or pharmacist about the most appropriate site to apply the patch. Do not apply the patch to your breasts. Do not apply patches to the same site on the skin twice in a row.

To apply the patch:

1. Choose a clean and dry area of intact skin that is not oily, damaged, irritated, or exposed to the sun. To avoid irritation, do not apply to the same site on the skin 2 times in a row.
2. Tear open the pouch containing the patch rather than using scissors – if you accidentally cut the patch, it will be useless.
3. Remove the protective layer. Apply the patch to the selected area immediately. Avoid touching the adhesive.
4. Use your fingers to hold the patch in place for about 10 seconds and make sure that the patch is affixed to your skin, especially around its edges.

When changing the patch, remove the old one carefully, fold it in half so that the adhesive sides stick together, and throw it away or bring it to the pharmacy for proper disposal. Keep it out of the reach of children or pets. If adhesive remains on your skin, rub it off gently.

Bathing, showering, swimming, or other contact with water does not affect the patch. However, hot water or steam may cause the patch to loosen. If your patch falls off, try to reapply it. If that doesn't work, apply a new patch.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you forget to apply or change your patch, change it as soon as you remember. If it is close to the day when you normally change your patch, still apply it but change the patch again on your usual day and continue on with your regular schedule. Do not wear 2 patches at once. If you are not sure what to do after forgetting to apply or change the patch, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children. Do not store the patches out of the pouch.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Do not use SEASONALE if you are pregnant or if you have recently had a baby.

You should not take SEASONALE if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

Taking SEASONALE can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take SEASONALE if you smoke and are over 35 years old.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your SEASONALE tablets.

Some drugs can make SEASONALE less effective in preventing pregnancy, including antibiotics, hepatitis C medications, HIV/AIDS medications, seizure medications, or barbiturate sedatives. Tell your doctor about all other medications you use.

Before taking this medicine

Taking SEASONALE can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking SEASONALE. Your risk is also high when you restart taking SEASONALE after not taking it for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take SEASONALE if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take SEASONALE if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
• a blood-clotting disorder or circulation problems;
• problems with your eyes, kidneys or circulation caused by diabetes;
• a history of hormone-related cancer such as breast or uterine cancer;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills; or
• if you smoke and are over 35 years old.

To make sure SEASONALE are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;
• high cholesterol or triglycerides, or if you are overweight;
• a history of depression;
• diabetes, underactive thyroid, gallbladder disease;
• seizures or epilepsy;
• a history of irregular menstrual cycles;
• tuberculosis; or
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in SEASONALE can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use SEASONALE if you are breast feeding a baby.

Get emergency medical help if you have signs of an allergic reaction to SEASONALE: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using SEASONALE and call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• sudden cough, wheezing, rapid breathing, coughing up blood;
• pain, swelling, warmth, or redness in one or both legs;
• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;
• a change in the pattern or severity of migraine headaches;
• nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Common SEASONALE side effects may include:

• mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
• breast tenderness or swelling, nipple discharge;
• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge; or
• changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 

Some drugs can make SEASONALE less effective, which may result in pregnancy. Other drugs may interact with ethinyl estradiol and levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Take SEASONALE exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using SEASONALE. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

You will not have a menstrual period every month while you are taking an extended-cycle birth control pill. Instead, your period should occur every 12 weeks.

The 91-day birth control pack contains three trays with cards that hold 84 "active" pills and seven "reminder" pills. You must use the pills in a certain order to keep you on a regular cycle. Trays 1 and 2 each hold 28 pills. Tray 3 holds 35 pills, including the 7 reminder pills. Your period should begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using SEASONALE for a short time. Any doctor or surgeon who treats you should know that you are using SEASONALE.

While taking SEASONALE, you will need to visit your doctor regularly.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss three "active" pills in a row, do not take the missed pills. Continue taking 1 pill per day on schedule according to the pill package and leave the missed pills in the package. You may have some bleeding or spotting if you miss three pills in a row. Use back-up birth control for at least the next 7 days.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill. If your period does not start while you are taking the reminder pills, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking SEASONALE?

Do not smoke while taking SEASONALE, especially if you are older than 35 years of age.

SEASONALE will not protect you from sexually transmitted diseases - including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Do not use SEASONIQUE if you are pregnant or if you have recently had a baby.

You should not take SEASONIQUE if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

Taking SEASONIQUE can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take SEASONIQUE if you smoke and are over 35 years old.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your SEASONIQUE tablets.

Some drugs can make SEASONIQUE less effective in preventing pregnancy, including antibiotics, hepatitis C medications, HIV/AIDS medications, seizure medications, or barbiturate sedatives. Tell your doctor about all other medications you use.

Before taking this medicine

Taking SEASONIQUE can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking SEASONIQUE. Your risk is also high when you restart SEASONIQUE after not taking it for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take SEASONIQUE if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using SEASONIQUE and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking SEASONIQUE.

You should not take SEASONIQUE if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
• a blood-clotting disorder or circulation problems;
• problems with your eyes, kidneys or circulation caused by diabetes;
• a history of hormone-related cancer such as breast or uterine cancer;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills; or
• if you smoke and are over 35 years old.

To make sure SEASONIQUE are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;
• high cholesterol or triglycerides, or if you are overweight;
• a history of depression;
• diabetes, underactive thyroid, gallbladder disease;
• seizures or epilepsy;
• a history of irregular menstrual cycles;
• tuberculosis; or
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in SEASONIQUE can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

Get emergency medical help if you have signs of an allergic reaction to SEASONIQUE: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using SEASONIQUE and call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• sudden cough, wheezing, rapid breathing, coughing up blood;
• pain, swelling, warmth, or redness in one or both legs;
• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;
• a change in the pattern or severity of migraine headaches;
• nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Common SEASONIQUE side effects may include:

• mild nausea (especially when you first start taking SEASONIQUE), vomiting, bloating, stomach cramps;
• breast tenderness or swelling, nipple discharge;
• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge; or
• changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Some drugs can make SEASONIQUE less effective, which may result in pregnancy. Other drugs may interact with ethinyl estradiol and levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Take SEASONIQUE exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

You will not have a menstrual period every month while you are taking an extended-cycle birth control pill. Instead, your period should occur every 12 weeks.

The 91-day birth control pack contains three trays with cards that hold 84 "active" pills and seven "reminder" pills. You must use the pills in a certain order to keep you on a regular cycle. Trays 1 and 2 each hold 28 pills. Tray 3 holds 35 pills, including the 7 reminder pills. Your period should begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using SEASONIQUE.

While taking SEASONIQUE, you will need to visit your doctor regularly.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss three "active" pills in a row, do not take the missed pills. Continue taking 1 pill per day on schedule according to the pill package and leave the missed pills in the package. You may have some bleeding or spotting if you miss three pills in a row. Use back-up birth control for at least the next 7 days.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill. If your period does not start while you are taking the reminder pills, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking SEASONIQUE?

Do not smoke while taking SEASONIQUE, especially if you are older than 35 years of age.

SEASONIQUE will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Serious Warnings and Precautions

Hypersensitivity Reactions: You should be screened for the HLA-B*5701 gene variation prior to starting or re-starting treatment with TRIUMEQ. Patients who have the HLA-B*5701 gene variation have a high risk of developing a hypersensitivity reaction (serious allergic reaction) to abacavir, which is in the drug TRIUMEQ. This hypersensitivity reaction can be life threatening if you continue to take TRIUMEQ.

Build-up of acid in your blood (lactic acidosis) and swollen and fatty liver: Lactic acidosis (too much acid in the blood) and swollen and fatty liver (hepatomegaly with steatosis), including fatal cases, have been reported using nucleoside analogues alone or in combination. If you suffer symptoms (see Table Serious Side Effects, How Often They Happen and What to Do About Them), contact your doctor.

Worsening of hepatitis B virus in people who have HIV-1 infection: If you have a hepatitis B infection, you should not stop taking TRIUMEQ without instructions from your doctor as your hepatitis may worsen or reoccur. Your doctor will monitor your conditions for several months after stopping treatment with TRIUMEQ.

If you stop TRIUMEQ because of a serious allergic reaction, never take TRIUMEQ or any other medicine containing abacavir or dolutegravir (such as ZIAGEN, KIVEXA, TRIZIVIR, or TIVICAY) again, regardless of whether you have the HLA-B*5701 gene variation or not. Within hours you may experience a life threatening lowering of your blood pressure or death. If you stop TRIUMEQ for any other reason, even for a few days, and you are not allergic to TRIUMEQ, talk with your doctor before taking it again. Taking TRIUMEQ again may cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.

If your healthcare provider tells you that you can take TRIUMEQ again, start taking it when you are around medical help or people who can call a doctor if you need one.

BEFORE you use TRIUMEQ talk to your doctor or pharmacist:

• If you have had previous use of any NRTI class medicine.
• If you have been tested and know whether or not you have a gene variation called HLA-B*5701
• If you have kidney or liver problems, including hepatitis B or C
• If you are taking interferon or ribavirin
• If you are pregnant or plan to become pregnant; do not take TRIUMEQ without speaking with your doctor first. Babies and infants exposed to medicines containing Nucleoside Reverse Transcriptase Inhibitors (NRTIs) during pregnancy or labour show minor temporary increases in blood levels of lactate. There have also been very rare reports of disease that affect babies’ nervous systems such as delayed development and seizures. These finding do not affect current recommendations to use antiretroviral therapy in pregnant women to prevent transmission of HIV to their babies. Your doctor will consider the benefit to you and the risk to your baby when taking TRIUMEQ while pregnant. If you take TRIUMEQ while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
• If you are breastfeeding or plan to breastfeed. Where possible, women who are HIV positive should not breastfeed, because HIV infection can pass into breast milk and harm your baby. Abacavir and lamivudine, components of TRIUMEQ, can pass into breast milk. Talk to your doctor about how to feed your infant.
• If you have any other medical condition
• About all your medicines you are taking including vitamins, herbal supplements and non-prescription drugs

Other special warnings:

Two components of TRIUMEQ (abacavir sulfate and lamivudine) belong to a class of medicines (NRTIs) that can cause a condition called lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver. Symptoms of lactic acidosis include feeling of weakness, loss of appetite, sudden unexplained weight loss, upset stomach and difficulty breathing or rapid breathing. This rare but serious side effect occurs more often in women. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with TRIUMEQ your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

If you have hepatitis B infection, you should not stop TRIUMEQ without instructions from your doctor, as you may have recurrence of your hepatitis. This may occur due to you suddenly stopping the active ingredient lamivudine in TRIUMEQ.

Some HIV medicines including abacavir may increase your risk of heart attack. If you have heart problems, smoke or suffer from diseases that increase your risk of heart disease such as high blood pressure and diabetes, tell your doctor. Do not stop taking your medication unless you are advised to do so by your doctor.

You may continue to develop other infections and other illnesses associated with HIV disease. You should therefore keep in regular contact with your doctor while taking TRIUMEQ.

Remember: This medicine is for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

Like all medicines, TRIUMEQ can have side effects. When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by TRIUMEQ, by other medicines you are taking at the same time or by the HIV infection. For this reason it is very important that you inform your doctor about any changes in your health.

A hypersensitivity reaction (serious allergic reaction) has been reported in patients who have been treated with abacavir containing products.

TRIUMEQ contains dolutegravir, abacavir and lamivudine. The most common side effects for this combination are nausea, vomiting, diarrhea, abdominal pain and bloating (abdominal distension), headache, high temperature (fever), lethargy (unusual lack of energy), fatigue, trouble sleeping, depression/depressed mood (feelings of deep sadness and unworthiness), loss of appetite, hair loss, joint and muscle pain, abacavir hypersensitivity (serious allergic reaction) and skin rash (without any other illness). If these symptoms persist or become bothersome, contact your doctor.

Other side effects include, stomach discomfort, dizziness, abnormal dreams, suicidal thoughts and behaviours (mainly in patients who have had depression or mental health problems before) and intestinal gas (flatulence). Very rare side effects include serious skin reactions and severe anemia.

Changes in body fat have been seen in patients taking antiretroviral therapy. These changes may include increased amount of fat on the upper back and neck (“buffalo hump”), breasts and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions is not known at this time.

Side effects that may show up in blood tests include an increase in bilirubin (a substance produced by the liver), and/or an increase in the level of enzymes produced in the muscles (creatine phosphokinase, creatinine).

Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Graves' disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor immediately.

Inflammation of the pancreas (pancreatitis) has been observed in patients treated with abacavir and lamivudine, although it was not clear whether this was due to the medicine or the HIV infection itself (see Table Serious Side Effects, How Often They Happen and What to Do About Them). If your doctor detects clinical signs, symptoms or lab tests suggestive of pancreatitis, they will stop treatment with TRIUMEQ immediately.

No drug interaction studies have been done with the fixed dose combination, TRIUMEQ. Tell your healthcare provider about all prescription and non-prescription medications listed below or any that you are taking; including any vitamins, herbal supplements, and dietary supplements. Some drugs may interact with TRIUMEQ and can affect how TRIUMEQ works, or make it more likely that you will have side effects. These include:

• metformin, to treat diabetes
• medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take TRIUMEQ, or for at least 2 hours after you take it.
• calcium or iron supplements. Do not take these supplements during the 6 hours before you take TRIUMEQ, or for at least 2 hours after you take it. If you take food with TRIUMEQ, then you can take calcium and iron supplements at the same time as TRIUMEQ.
• etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, zalcitabine (HIVID, ddc) to treat HIV infection
• rifampin, to treat tuberculosis (TB) and other bacterial infections
• phenytoin and phenobarbital, to treat epilepsy
• oxcarbazepine and carbamazepine, to treat epilepsy and bipolar disorder
• St. John’s Wort, (Hypericum perforatum), a herbal remedy to treat depression
• retinoids
• trimethoprim sulphamethoxazole (co-trimoxazole, an antibiotic used to treat PCP—Pneumocystis carinii pneumonia or toxoplasmosis)
• interferon and/or ribavirin
• medicines that already contain abacavir, lamivudine or emtricitabine such as 3TC, HEPTOVIR, COMBIVIR, ZIAGEN, TRIZIVIR, KIVEXA, TRUVADA, COMPLERA, ATRIPLA, EMTRIVA and STRIBILD

If you are taking methadone, your doctor may need to adjust your methadone dose, as abacavir increases the rate at which methadone leaves your body. This is unlikely to affect most methadone users.

Usual dose:

The usual dose in adults (18 years and older) is one tablet once a day. Swallow the tablet whole with water or some liquid. TRIUMEQ can be taken with or without food.

TRIUMEQ is a set (fixed) dose combination of dolutegravir, abacavir and lamivudine, and therefore cannot be dose reduced. Therefore, TRIUMEQ cannot be used if you have certain kidney or liver problems because you cannot change the dose. If you are unsure about how to take it, ask your doctor or pharmacist.

Overdose:

If you take too many tablets of TRIUMEQ, contact your doctor or pharmacist for advice. If possible, show them the TRIUMEQ pack.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose, take it as soon as you remember, but if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.

If you stopped taking TRIUMEQ:

If you stop taking TRIUMEQ because of side effects or illness, you must contact your doctor before restarting to make sure that symptoms of a hypersensitivity reaction have not been missed. In some cases your doctor will ask you to restart TRIUMEQ under direct medical supervision or in a place where you will be able to get ready access to medical care if needed.